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New lifestyle program aims to get heart defect patients moving

NCT ID NCT06003023

Disease control Sponsor: Jamie Jackson Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a lifestyle program designed to help teens and young adults (ages 15-25) with congenital heart disease become more physically active. Participants will receive a Fitbit, a personalized exercise plan, and education on healthy living. The goal is to see if the program increases moderate-to-vigorous physical activity and improves attitudes toward exercise.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lifestyle intervention (physical activity monitoring, tailored exercise prescription, and healthy lifestyle education)
What this could lead to
If successful, this program could help teens and young adults with congenital heart disease become more active and improve their long-term heart health.
What could go wrong
This is a relatively small, early-stage trial (144 participants) focused on behavior change, so results may not apply to everyone. Participants may not stick with the program long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 25 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Between the ages of 15-25 years * Diagnosed with moderate or complex structural CHD * Actively receiving care from a cardiologist at Nationwide Children's Hospital (NCH) or Ohio State University (OSU) Exclusion Criteria: * Unable to speak and read proficiently in English * Have a diagnosis of a genetic syndrome that impacts multiple organ systems * Have cognitive impairments that would interfere with completing study measures * Have been engaged in a formal exercise program within the past 6 months, * Have participated in the intervention arm of the previous CHD-PAL Study * Have undergone open-heart surgery or had a valve replacement in the last 3 months * Are unable to complete an exercise stress test using a treadmill * Are pregnant * Are prohibited to engage in at least moderate levels of physical activity by their cardiologist * Engage in \>30 minutes of moderate-to-vigorous physical activity per day, on average per accelerometer * Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia)

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder congenital heart disease Motor Activity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular disease other Heart defects, congenital

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

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